Chemo Hiring Regulatory Affairs

MPharm Regulatory Affairs Jobs Chemo Hyderabad

M.Pharm candidates apply for Regulatory Affairs roles at Chemo India Hyderabad with 4–5 yrs experience.

Chemo India Formulation Pvt. Ltd is actively hiring experienced professionals for Regulatory Affairs roles in Hyderabad. This opportunity is ideal for candidates seeking regulatory affairs jobs in pharmaceutical formulation, especially those with exposure to US market submissions and injectable product dossiers.

If you have hands-on experience in pharmaceutical regulatory compliance, dossier preparation, and global market submissions, this role offers a strong career path in high-value pharma regulatory jobs with international exposure.

Company Overview

Chemo India Formulation Pvt. Ltd is part of the globally recognized Chemo Group, known for its strong footprint in pharmaceutical formulations, injectables, and regulated markets. The company operates with strict adherence to global regulatory standards such as USFDA, EU-GMP, and WHO-GMP.

Working at Chemo provides direct exposure to regulated markets including the US and ROW (Rest of World) regions, making it a strong platform for professionals aiming to grow in pharmaceutical regulatory affairs and compliance domains.

Job Role & Responsibilities

Regulatory Affairs Executive

• Prepare and review regulatory dossiers for US and global markets (CTD/eCTD formats)
• Handle submission of ANDA/DMF-related documentation for formulations and injectables
• Manage lifecycle activities including variations, renewals, and post-approval changes
• Coordinate with cross-functional teams for regulatory submissions and documentation
• Ensure compliance with USFDA, WHO-GMP, and international regulatory guidelines
• Conduct gap analysis and support regulatory strategy for product approvals

Eligibility / Qualifications

Educational Qualification

• B.Pharm / M.Pharm (Regulatory Affairs preferred)

Relevant Courses: Regulatory Affairs, Pharmaceutics, Pharmaceutical Chemistry, Drug Regulatory Affairs, Clinical Research, Quality Assurance

Experience Required

• 4 to 5 years of experience in regulatory affairs
• Experience in US market submissions, formulations, and injectables

Key Skills

• CTD/eCTD dossier preparation and submission
• USFDA regulatory compliance and documentation
• Injectable and formulation regulatory exposure
• Lifecycle management and variation filing
• Strong coordination and regulatory writing skills

Location & Salary

• Location: Madhapur, Hyderabad, Telangana
• Salary: Competitive based on experience (₹6–12 LPA estimated)

Application Process

• Interested candidates can apply via email
• Email: jagadish.s@chemogroup.com
• Interview Venue:
  Chemo India Formulation Pvt. Ltd
  Gowra Fountainhead, HUDA Techno Enclave Road,
  Madhapur, Hyderabad, Telangana

Why This Opportunity Stands Out

• Work with a globally recognized pharmaceutical group
• Exposure to USFDA and regulated market submissions
• Opportunity to work on injectables and complex formulations
• Strong career growth in pharmaceutical regulatory affairs

High CPC Keywords Included

• Regulatory affairs jobs pharma Hyderabad
• USFDA regulatory jobs India
• CTD dossier preparation pharma jobs
• Injectable formulation regulatory jobs
• Pharma compliance jobs US market

FAQs

Who can apply for Chemo India Regulatory Affairs jobs?

Candidates with B.Pharm or M.Pharm and 4–5 years of regulatory experience can apply.

Is USFDA experience required?

Yes, experience in US market submissions is required.

What are ROW markets in pharma?

ROW (Rest of World) refers to countries outside major regulated markets like the US and EU.

What is CTD in regulatory affairs?

CTD is a standardized format for submitting regulatory documents globally.

What is the job location?

Hyderabad, Telangana.

Additional SEO Titles

• Regulatory Affairs Jobs Hyderabad USFDA Companies
• Injectable Pharma Regulatory Jobs India
• CTD eCTD Submission Jobs Pharma Industry

Summary Table

Category	Details
Company	Chemo India Formulation Pvt. Ltd
Vacancies	Regulatory Affairs Executive
Required Education	B.Pharm, M.Pharm
Experience	4–5 Years